Brassiere apparatus for propagating therapeutic electromagnetic fields

ABSTRACT

A brassiere is configured to administer electromagnetic therapy to treat a cancerous tumor within a breast. The brassiere includes at least one cup, the cup within its walls at least two magnetic coils (also referred to herein as solenoid coils). Each solenoid coil is energized, when in therapeutic operation, with a distinct time-domain signal. The time domain signal consists of a series of summed sinusoidal waves from a power supply. The coils are oriented within the wall of the cup such that for any two coils a first magnetic coil and a second magnetic coil are oriented relative to each other so as to be nonparallel. The purpose of having two distinct coils is to focus resultant magnetic fields such that at a tumor site within a volume of breast tissue the cup encloses to form a local maximum formed by superposition within the cancerous tumor.

FIELD OF THE INVENTION

The present invention relates generally to brassieres, and in particularto a brassiere wherein cups of the brassier include solenoid coils forfocused formation of electric and magnetic fields within the volume ofthe breast each cup encloses.

BACKGROUND OF THE INVENTION

The American Cancer Society's estimates for breast cancer in the UnitedStates for 2016 are:

-   -   About 246,660 new cases of invasive breast cancer will be        diagnosed in women.    -   About 61,000 new cases of carcinoma in situ (CIS) will be        diagnosed (CIS is non-invasive and is the earliest form of        breast cancer).    -   About 40,450 women will die from breast cancer.

Breast cancer most commonly develops in cells from the lining of milkducts and the lobules that supply the ducts with milk. Cancersdeveloping from the ducts are known as ductal carcinomas, while thosedeveloping from lobules are known as lobular carcinomas. In addition,there are more than 18 other sub-types of breast cancer. Some cancers,such as ductal carcinoma in situ, develop from pre-invasive lesions. Thediagnosis of breast cancer is confirmed by taking a biopsy of theconcerning lump. Once the diagnosis is made, further tests are done todetermine if the cancer has spread beyond the breast and to whichtreatments it may respond.

Most breast cancers are carcinomas, a type of cancer that starts in theepithelial cells that line organs and tissues like the breast. In fact,breast cancers are often a type of carcinoma called adenocarcinoma,which is carcinoma that starts in glandular tissue. Other types ofcancers can occur in the breast, too, such as sarcomas, which start inthe cells of muscle, fat, or connective tissue. In any case, however,the cancer, in its early and most treatable stages is a highly-localizedstructure within the tissue that makes up the breast. For that reason, ahighly focused application of any curative regimen is desired; there isno need to treat the surrounding healthy cells. The scope of thisembodiment of the instant invention relates to these localized canceroustumors and not to, for example, inflammatory breast cancer. Because theselected structures for treatment are highly localized, there is noreason to subject the whole of the breast structure where the cancerouscells are contained within a defined volume within the whole of thebreast. To the greatest extent possible, the ideal solution woulddeliver the therapeutic treatment only to affected tissue while leavingthe healthy structures alone or minimally involved.

Chemotherapy is the use of drugs to destroy cancer cells, which work bystopping the cancer cells' ability to grow and divide. A chemotherapyregimen (schedule) consists of a specific treatment schedule of drugsgiven at repeating intervals for a set period of time. Chemotherapy maybe given on many different schedules depending on what worked best inclinical trials for that specific type of regimen. It may be given oncea week, once every two weeks (also called dose-dense), once every threeweeks, or even once every four weeks. Common ways to give chemotherapyinclude an intravenous (IV) tube placed into a vein using a needle or ina pill or capsule that is swallowed. As is evident, however, such atreatment involves the whole of the circulatory system and all tissue incontact with the circulating blood receiving chemical agents from the IVtube or the whole of the digestive system and such tissue as receivesthe chemical agents by means of digestion. As such, a great many healthystructures are dosed with the chemotherapeutic chemical agents whichhave no need for treatment.

Chemotherapy is predominantly used for cases of breast cancer in stages2-4, and is particularly beneficial in estrogen receptor-negative (ER-)disease. The chemotherapy medications are administered in combinations,usually for periods of three to six months. One of the most commonregimens, known as “AC”, combines cyclophosphamide with doxorubicin.Sometimes a taxane drug, such as docetaxel, is added, and the regime isthen known as “CAT”. Another common treatment is cyclophosphamide,methotrexate, and fluorouracil (or “CMF”). Most chemotherapy medicationswork by destroying fast-growing or fast-replicating cancer cells, eitherby causing DNA damage upon replication or by other mechanisms. However,the medications also damage fast-growing normal cells, which may causeserious side effects. Damage to the heart muscle is the most dangerouscomplication of doxorubicin, for example.

The side effects of chemotherapy depend on the individual, the drug(s)used, and the schedule and dose used. These side effects can includefatigue, risk of infection, nausea and vomiting, hair loss, loss ofappetite, and diarrhea. Naturally, these side effects are undesirableand to avoid these side effects while still benefiting from thetherapeutic effects the chemotherapy could cause would be highlydesirable.

On a molecular level, the listed chemical agents used in chemotherapycause changes in the molecular structure of cancerous cells. Themolecules that make up the chemotherapeutic effectors interact withtarget biological systems through various physicochemical forces, suchas ionic, charge, or dispersion forces or through the cleavage orformation of covalent or charge-induced bonds. These changes effected byphysicochemical forces, necessarily assert field effects, i.e.electrostatic and magnetic field effects. Each of the changes involvethe movement of charge from one molecular structure to another. Becauseof these physicochemical-induced movements of charge during interaction,detection of field effects present a record of the chemotherapeuticinteractions.

Chemical reactions involve, among other things, the exchange ofelectrons between valence shell electrons to form or separate compoundmolecules. Movement of electrons is known as current and that electronmovement forms corresponding magnetic fields. Electric and magneticfields are fundamental in nature and can exist in space far from thecharge or current that generates them. Every charged object sets up anelectric field in the surrounding space. A changing magnetic fieldproduces an electric field, as the English physicist Michael Faradaydiscovered in work that forms the basis of electric power generation.Faraday's law of induction describes how a time-varying magnetic fieldproduces an electric field. Conversely, a changing electric fieldproduces a magnetic field, as the Scottish physicist James Clerk Maxwelldeduced. Thus, when a first charge moves from a valence shell of anatom, a second charge “feels” the presence of this movement due to thefields produced. The second charge is either attracted toward theinitial charge or repelled from it, depending on the signs of thecharges. Of course, since the second charge also has an electric field,the first charge feels its presence and is either attracted or repelledby the second charge, too. In short, every chemical reaction causeselectrical and magnetic fields to form that are characteristic of thatchemical reaction and those fields are detected by other electronswithin a given proximity to those fields.

Several have postulated that the chemotherapeutic interactions between achemical effector and a biological target may not require the presenceof the effector itself. Even without the presence of the effector, theobject is to induce the same changes in the target by generating fieldeffects associated with effector molecules from signals sensed duringaction upon targets by effector molecules. By sensing the movement ofelectrons in successful chemotherapy through recording the generatedfields resulting from that movement, the premise asserts that recreatingthose magnetic and electric fields is sufficient to produce the sametherapeutic results without requiring the presence of the chemicaleffector.

Recognizing that effecting cellular level changes in biological targetsby reproducing the suitable electrical and magnetic fields marks thepioneering works of the scientists of Nativis, Inc. as those works areset forth in white papers, patents and patent applications, the instantinvention produces highly localized electrical and magnetic fieldeffects. Reducing and eliminating tumors by producing magnetic andelectric fields are the gravamen of several studies undertaken toexamine the interaction between effector-molecule signals and biologicaltargets. For example, PCT applications WO 2006/073491 A2 and WO2008/063654 A2, both of which are incorporated by reference herein,teach the application of low-frequency time-domain signals to duplicatefield effects the researchers had earlier recorded. These recordedsignals comprise low-frequency time domain signals sensed and recordedas emanating from the interaction of one of several bio-active compoundsand a biological target such as a matrix of cells (the researchers hadisolated these signals observing the application of effectors to inducecompound-specific effects in biological target systems). The followingis a direct quote from United States Patent Published Application2011/0195111 entitled “Aqueous Compositions and Methods” and owned byNativis, Inc.:

-   -   PCT application WO 2006/073491, published Jul. 13, 2006        discloses studies in which (a) low-frequency time-domain signals        recorded for L(+) arabinose were shown to induce the araC-PBAD        bacterial operon, as discussed on pages 47-50 of the        application, with respect to FIGS. 30C-30F; (b) low-frequency        signals recorded for glyphosphate, the active ingredient in a        well-known herbicide, were shown to substantially inhibit stem        growth in pea sprouts, as discussed on pages 50-51 of the        application, with respect to FIGS. 31 and 32A and 32B; (c)        low-frequency signals recorded for gibberelic acid, a plant        hormone, were shown to significantly increase average stem        length in live sugar pea sprouts, as discussed on pages 51-53 of        the application, with respect to FIG. 33; and (d) low-frequency        signals recorded for phepropeptin, a proteasome inhibitor, were        shown to decrease the activity of the 20S proteosome enzyme, as        discussed on pages 53-54 of the application, with respect to        FIG. 34.    -   WO 20081063654 A2, published May 9, 2008, details studies in        which low-frequency time-domain signals for the anti-tumor        compound paclitaxel, generated in accordance with methods        disclosed herein, were shown to be effective in reducing tumor        growth in animals injected with glioblastoma cells, when the        animals were exposed to an electromagnetic field generated by        the signal over a several-week period.    -   Among the findings from the studies described above is that the        ability of agent-specific, time-domain signals to transduce        (affect) a biochemical or biological target system can be        optimized by a number of strategies. One of these strategies        involves scoring recorded time-domain signals by one or more        scoring algorithms to identify those signals that contain the        highest spectral information. This scoring is used to screen        recorded time-domain signals for those that are most likely to        give a strong transduction effect. An improvement in this        strategy is to record time-domain signals at each of a number of        different magnetic-signal injection conditions, by injecting        different levels of white noise or DC offset during recording,        and scoring the resulting signals for highest spectral        information. These strategies are detailed in both of the        above-cited PCT applications.    -   A third strategy, disclosed in the '654 application, is designed        particularly for applications in which a recorded time-domain        signal is intended for transducing an animal system, for        example, for treating a disease condition in a subject. The        strategy involves screening time-domain signals for their        ability to effectively transduce an in vitro target system that        includes at least some of the critical biological response        components of the animal system. The strategy has the advantage        that a large number of candidate signals can be easily screened        for actual transduction effect, to identify optimal transducing        signals. The strategy is preferably combined with one or both of        the above signal-scoring methods, using the highest-scoring        signals as candidates for the in vitro transduction screening.    -   Independently, a number of scientific groups have reported on        the structure and stability of clustered water in pure and        solute-containing water samples, including structured water        formed at interfaces. See, for example, studies cited in the        websites of Dr. Rustum Roy, late of the Pennsylvania State        University (rustumroy.com); Dr. Gerald Pollack at the University        of Washington        (www.depts.washington.eduibioe/people/core/pollack.html)); Dr.        Martin Chaplin of the London South Bank University        (l.lsbu.ac.uk/wate); and Dr. Emilio Del Guidice        (isi.it/progetti/workshop-complexity09/pres_DelGiudice.pdf).        Among the findings of these groups is that water interacts with        electromagnetic radiation to form stable macroscopic structures        that can be detected by a number of physical and spectroscopic        tools; (See, for example, del Guidice, E., et al., Physical        Review, 74:022105-1 (2006); Pollack, G.,        uwtv.org/programs/displayevent.aspx?rID=22222): Chai, B. et        al, J. Phys. Chem. B, 2009, 113:13953-13958; Rao, M. L., et al.,        Current Science Research Communications, 98(1); 1500, June 2010.

The application sets out a method of forming an aqueous compositioneffective to produce an agent-specific effect on an agent-responsivechemical or biological system, when the composition is added to thesystem. The method includes the steps of:

-   -   (a) placing an aqueous medium within the sample region of an        electromagnetic-coil device; and    -   (b) exposing the aqueous medium to a magnetic field generated by        supplying to the device, a low-frequency, time-domain        agent-specific signal, at a signal current calculated to produce        a magnetic field strength in the range between 1 G (Gauss) and        10.sup.-8 G, for a period sufficient to render the aqueous        medium effective to mimic one or more agent-specific effects on        an agent-responsive system.

The low-frequency, time domain signal used in step (b) may be producedby the steps of:

-   -   (i) placing in a sample container having both magnetic and        electromagnetic shielding, an aqueous sample of the agent,        wherein the sample acts as a signal source for low-frequency        molecular signals; and wherein the magnetic shielding is        external to a cryogenic container;    -   (ii) recording one or more time-domain signals composed of        sample source radiation in the cryogenic container, and    -   (iii) identifying from among the signals recorded in step (ii),        a signal effective to mimic the effect of the agent in an        agent-responsive system, when the system is exposed to a        magnetic field produced by supplying the signal to        electromagnetic transducer coil(s) at a signal current        calculated to produce a magnetic field strength in the range        between 1 G to 10.sup.-8 G.

The inventor of the instant invention makes no assertion as to thisscience but adopts each of the recited applications in their entirety bythe above set-out references. Rather, the inventor, acknowledging thescience those references contain seeks, instead, to teach and claim theuse of a particularized garment having a plurality of solenoids for theselective propagation of low-frequency, time-domain agent-specificsignals throughout selected tissue of a human patient for therapeuticpurposes. Nonetheless, the inventor notes that Nativis' flagship therapyand device known together as Voyager is amid clinical trials to “assessthe effects of the Nativis Voyager™ therapy in patients with recurrentGBM who have either failed standard of care or are intolerant totherapy. The study will enroll and treat up to 64 subjects of which 32will be treated with the Voyager therapy alone (monotherapy) and 32 willbe treated with Voyager plus concurrent chemotherapy. Safety andclinical utility will be evaluated. See, “A Feasibility Study of theNativis Voyager™ System in Patients with Recurrent GlioblastomaMultiforme (GBM)” having ClinicalTrials.gov Identifier: NCT02296580.

There is a need for a garment to administer therapeutic electromagneticfields effectively and discretely to women afflicted by breast cancer.Psychologists recognize a historic aversion among women to be identifiedas undergoing treatment for breast cancer. The earliest research on thepsychological impact of breast cancer focused its attack on femininity,with amputation of the breast, and subsequent threat to sexualattractiveness. In addition to these concerns, the life-threateningnature of cancer itself contributed to psychological distress. Thestress of breast cancer has been described as arousing depression,anxiety, and anger. In some of the first systematic and comparativestudies, mastectomy patients were found to be more distressed than womenwith benign lumps, and often this distress persisted for more than ayear following surgery. Patients treating for breast cancer reportchanges in life patterns that resulted from the diagnosis and surgicaltreatment of breast cancer, including insomnia, recurrent nightmares,loss of appetite, difficulty returning to usual household activities andwork, and inability to concentrate.

While noninvasive treatment usually means treatment without surgery,ideally noninvasive treatment of breast cancer means that the treatmentalso does not invade the life activities of the treated patient. Forthis reason, it is desired that the treatment of breast cancer is to beas inconspicuous as possible. To avoid the stigma of any clear therapyfor breast cancer, what is needed in the art is a means of making thetherapy less evident while not in any way diminishing the effectivenessof that therapy. What is needed in the art is a means of facilitatingthe therapeutic use of solenoids near the targeted tissue of the breastwithout unwarranted disclosure of the presence of the tumor within thetargeted tissue.

SUMMARY OF THE INVENTION

A brassiere is configured to administer electromagnetic therapy to treata cancerous tumor within a breast. The brassiere includes at least onecup, the cup that includes, in its walls at least two magnetic coils(also referred to herein as solenoid coils). Each solenoid coil isenergized, when in therapeutic operation, with a distinct time-domainsignal. The time-domain signal consists of a series of summed sinusoidalwaves from a power supply. The coils are oriented within the wall of thecup such that for any two coils a first magnetic coil and a secondmagnetic coil are oriented relative to each other so as to benonparallel. The purpose of having two distinct coils is to focusresultant magnetic fields such that at a tumor site within a volume ofbreast tissue the cup encloses to form a local maximum formed bysuperposition within the cancerous tumor.

The brassiere may, optionally, include a third magnetic coil to receivea third time-domain signal consisting of a third series of summedsinusoidal waves from a third power supply. Just as with the first twomagnetic coils, the first magnetic coil and the second magnetic coil,the third magnetic coil is oriented to be perpendicular relative to theothers such that each pair of magnetic coils is nonparallel one to theother. The distinct signals that energize the three coils are selectedto create by superposition a designated field at the site of the tumorwithin the volume the therapeutic cup encloses. These signals aredefined by a first set of coefficients in the first Fourier series, asecond set of coefficients in the second Fourier series, and a third setof coefficients in a third Fourier series and are selected such that aresultant second combined electrical signal formed by superpositionforms a local maximum field at the site of a cancerous tumor.

In another embodiment, a fourth magnetic coil is included within thewall of the therapeutic cup to receive a fourth time-domain signalwhich, likewise, can be defined by a fourth series of summed sinusoidalwaves from a fourth power supply. As in the other embodiments, thefourth series of summed sinusoidal waves is also representable as afourth set of coefficients in a fourth Fourier series. These areselected such that the first magnetic coil, the second magnetic coil,the third magnetic coil, and the fourth magnetic coil are orientedrelative to each other such that each pair of magnetic coils isnonparallel one to the other. Also, likewise, the first set ofcoefficients in the first Fourier series, the second set of coefficientsin the second Fourier series, the third set of coefficients in the thirdFourier series, and the fourth set of coefficients in the fourth Fourierseries being selected such that a resultant third combined electricalsignal formed by superposition forms a local maximum at the canceroustumor.

This embodiment of the brassiere is configured such that each of thefirst, second, third and fourth magnetic coils are positioned within thebrassiere to approximate edges of four respective hulls that togetherapproximate a Reulecaux tetrahedron. A plurality of seams that make upthe brassiere cup are used to enclose the magnetic coils.

A method to administer electromagnetic therapy to treat a canceroustumor within a breast uses a brassiere having at least one therapeuticcup. The cup includes at least a first magnetic coil and a secondmagnetic coil. Part of the method includes energizing the first magneticcoil with a first time-domain signal which is summed from a first seriesof sinusoidal waves. Advantageously each series of sinusoidal waves maybe represented as a set of coefficients in Fourier series. Likewise, asecond magnetic coil is energized by a second time-domain signalconsisting of a second series of summed sinusoidal waves. The firstmagnetic coil and the second magnetic coil are oriented relative to eachother so as to be nonparallel, avoiding the structure of a Helmholtzcoil, thereby allowing the focusing of the resultant electromagneticfield rather than the uniform field created by a Helmholtz coil. Again,the first set of coefficients in the first Fourier series and the secondset of coefficients in second Fourier series are selected such that aresultant first combined electrical signal formed by superposition formsa local maximum at the cancerous tumor.

In another embodiment, the brassiere includes a third magnetic coilwhich is energized with a third time-domain signal consisting of a thirdseries of summed sinusoidal waves. Just as in the case of the first twosignals, the third signal is a series of summed sinusoidal waves alsorepresentable as a third set of coefficients in a third Fourier series.The brassiere cup includes the first magnetic coil, the second magneticcoil, and, now, the third magnetic coil which are oriented relative toeach other such that each pair of magnetic coils is nonparallel one tothe other. The electromagnetic field formed by superposition creates alocal maximum at the site of the cancerous tumor. To do so, the firstset of coefficients in the first Fourier series, the second set ofcoefficients in second Fourier series, and the third set of coefficientsin the third Fourier series are selected to create a localized field tomimic that of a therapeutic pharmaceutical agent in treatment of atumor.

A further embodiment of the method includes energizing a fourth magneticcoil the brassiere comprises with a fourth time-domain signal consistingof a fourth series of summed sinusoidal waves. As in the earlierembodiments, the fourth series of summed sinusoidal waves isrepresentable as a fourth set of coefficients in a fourth Fourierseries. The coils are oriented about the therapeutic cup such that thefirst magnetic coil, the second magnetic coil, the third magnetic coil,and the fourth magnetic coil are oriented relative to each other suchthat each pair of magnetic coils is nonparallel one to the other. Thefourth magnetic coil encircles the entrance of the cup. Now, themagnetic field is formed by distinctly energizing each coil withsignals. In each coil respectively, the signals include the first set ofcoefficients in the first Fourier series, the second set of coefficientsin the second Fourier series, the third set of coefficients in the thirdFourier series, and the fourth set of coefficients in a fourth Fourierseries; each Fourier series being selected such that a combinedelectromagnetic field formed by superposition forms a local maximum atthe site of the cancerous tumor.

As described above, the therapeutic cup of the first, second, third andfourth magnetic coils are positioned within the brassiere to approximateedges of four respective hulls that together approximate a Reuleauxtetrahedron. The brassiere cup includes a plurality of seams which arepositioned to enclose the magnetic coils in the Reuleaux tetrahedron.

The therapy the invention envisions may be administered using abrassiere assembly to administer electromagnetic therapy to treat acancerous tumor within a breast. The brassiere assembly includes abrassiere having at least one therapeutic cup, the therapeutic cupincluding a plurality of solenoid coils, the coils in nonparallelalignment, each to the others. The plurality of solenoid coils arepowered by a signal generator, independently energizing each of theplurality of solenoid coils. The signal generator includes a Fouriersumming engine to generate summed signals by summing of sinusoids basedupon Fourier coefficients provided to the summing engine.

The brassiere assembly is configured such that each of the plurality ofsolenoid coils receives a distinct signal based upon a distinct seriesof Fourier coefficients provided to the Fourier summing engine. Each ofthe distinct series of Fourier coefficients are selected to generate adesignated signal at a tumor site within a volume of breast tissue thetherapeutic cup encloses, summed from the influence of the plurality ofsolenoid coils based upon the superposition principle. In the preferredembodiment, the designated signal is selected to mimic electromagneticfields associated with therapeutic dosage of cancerous tissue with aselected anti-cancer drug.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred and alternative examples of the present invention aredescribed in detail below with reference to the following drawings:

FIG. 1 is a vector diagram depicting a magnetic field strength measuredat a point P resulting from a current I passing through a single coil ofa solenoid;

FIG. 2 demonstrates the principle of superposition of magnetic fieldsbased upon individual magnetic fields the two coils of a Helmholtz coilapparatus;

FIG. 3 is a diagram of a conventional brassiere indicating the locationof specific seams to conceal solenoid coils;

FIG. 4 represents a mapping of the bra cup onto the Reuleaux tetrahedronand the further explosion of the Reuleaux tetrahedron into the fourhulls; and

FIG. 5 depicts the selected energization of solenoids concealed withinseams of a conventional brassiere.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A solenoid is a wire coil wound into a tightly packed helix. When acurrent of electrons passes along the wire coil, it generates a magneticfield. The term was coined by French physicist André-Marie Ampere todesignate a helical coil. Just as electric fields created by differentsources, e.g., by two or more point charges, simply add together asvectors, similarly, magnetic fields created by different sources, e.g.,by two or more current-carrying wires, also add together as vectors.This is known as the superposition principle and applies to all electricand magnetic fields, including those comprising electromagnetic wavescreated by different sources. A Helmholtz pair consists of two identicalcircular magnetic coils (solenoids) that are placed symmetrically alonga common axis and when suitably energized, will produce a region ofnearly uniform magnetic field.

Circularity of the coils is not a necessary configuration to form amagnetic field. Consider that, when, rather than a precisely circular orhelical coil, the wire coil is allowed to take on a generally triangularshape, the current will still produce a magnetic field which ispredicable in its strength and distribution. The Biot-Savart lawdescribes a magnetic field generated by an electric current. The lawrelates the magnetic field to the magnitude, direction, length, andproximity of the electric current. FIG. 1 shows a circular conductorwith radius a that carries a current I. To express the magnetic field atpoint P on the axis of the loop, at a distance x from the centeraccording to the Biot-Savart Law:

$\overset{\rightharpoonup}{B} = {\frac{\mu_{0}}{4\pi}{\int{\frac{I}{r^{2}}d\overset{\rightharpoonup}{l} \times \hat{r}}}}$

A magnetic field decreases with the square of the distance from a “pointof current” or current segment. Thus, the Biot-Savart law provides meansto calculate the magnetic field created by an electric current flowingthrough an arbitrarily shaped wire. In fact, the mathematics forcalculating magnetic fields produced by irregularly shaped solenoids wasused in 1958 to build a stellarator to achieve plasma confinement in acontrolled nuclear fusion reaction. Similar calculations can predict,with precision, the number, shape, and position of coils that arerequired to generate a poloidal magnetic field. Importantly, the fieldvector indicating the changing magnetic field dB can be resolved intotwo orthogonal components dB_(x) and dB_(y). Thus, when adding magneticfield strength from distinct coils, there is no requirement that thecoils be similarly oriented to any arbitrary coordinate system in orderto resolve their individual and thus the sum of their individualcontributions.

According to the principle of superposition, two (or more) waves canexist in the same spatial location at the same time, and thereforeoverlap each other. Then one should add up their amplitudes at eachspatial location and time moment. FIG. 2 sets out the superpositionprinciple when applied to Heimholtz coils. The Heimholtz coil exampleset out here is simply to demonstrate superposition but is trivialrelative to placement of coils in a bra as the Heimholtz coils are, bydefinition, perfectly circular and have a radius of R which is also theseparation of the coils. Displacement of the coils is solely along thex-axis, so their contribution can be represented in the three graphsshown, i.e. the x-axis component of the magnetic field contributed byCoil 1, the x-axis component of the magnetic field contributed by Coil 2and Overall (meaning the sum of the x components of the two magneticfields). While not employed directly in the instant invention, theexample of the Heimholtz coils demonstrates the additive nature ofmagnetic (and, indeed, electric) fields as generated by the currentpassing around the two coils.

Computational methods have been applied to find resultant fields forcurrents passing through variously shaped and oriented coils when giveneach of their relative orientations to develop a desired field at thebiological target. That process is facilitated by a correlation betweenthe shape factors and corresponding Fourier coefficients, called thespectrum. When using the proper Fourier coefficients in an expansion,one can produce the desired magnetic field strength in terms of desiredangles. These coils should be smooth so they can be constructedeffectively and so they generate a magnetic field with robust fluxsurfaces devoid of extraneous harmonics. If the Fourier coefficientsthat occur are chosen carefully, the Biot-Savart separatrix thusobtained becomes a good enough facsimile of the fields observed in thecorresponding chemotherapeutic reaction to produce the therapeuticresult. Thus, by knowing the shape and location of the biological targetwithin a space tinder the influence of a multiplicity of coils, one canselectively energize each of the multiplicity of coils to produce ahighly-localized field that replicates the field produced by chemicalreactants upon the tumor. According to the earlier work referred to andincorporated above, the effect should be to reduce the tumor.

In the instant invention, the solenoids are positioned as windingsrunning along seams of bra cups. Because bra cups are designed toenclose and support the breast tissue, they provide a pair of relativelystable platforms upon which to fix the therapeutic coils relative to thebreast tissue and, therefore, relative to the biological target ortumor. When worn, the brassier or bra maintains a relatively fixedrelationship to the structure of the breast. A bra surrounds the breastcontacting the surface of the breast with seams that run, generally fromthe chest wall of a wearer to the tips of the nipples. As such, seams ofa brassier or bra can provide hiding places that can be used forpositioning solenoids relative to the position of the breast, thereby tofocus magnetic and electric fields at a tumor site within the breast.Advantageously, the shape and configuration of the bra is known to beacceptable to women and a woman's election to wear a bra is notsignificant of any health condition. Suitably hidden, then, the solenoidcoils do not advertise the presence or treatment of a tumor.

Because its structure has become conventional, there are components incommon with most bras and the known structure provides a lexicon fordescription. A common configuration for a bra 10 is shown in FIG. 3. Achest band 12 wraps around the torso of the wearer and that chest band12 provides the mechanical connection to each of two cups 14 forcontaining and supporting the breasts and shoulder straps 16 which fixthe position of the bra 19 relative to the shoulders of the wearer. Thechest band 12 is usually closed in the back by a hook 18 a and eye 18 bfastener, but may be fastened at the front. The chest band 12 and cups14, not the shoulder straps 16, are designed to support the weight ofwomen's breasts. The section between the cups is called a gore 22. Thesection under the armpit where the band joins the cups is called theback wing 24. Between the back wing 24 and the cup 14 on each side is acradle 20 which helps position the cups securely against the chest. Manywomen therefore find bras with cradles more comfortable to wear.

Importantly, there remains the denotation of seams. To shape planarswatches of cloth around a breast, several seams are necessary to jointhe swatches and, thereby, to create a hollow to encompass the breast.The breast has a very complicated geometry. Morphologically the breastis a cone, with the base at the chest wall and the apex at the nipple,the center of the nipple-areola complex. Due to both effects of gravityand the nature of the breast tissue, the superior pole of the breast isgenerally shaped as a half a cone while the inferior pole resembles ahalf a globe. As with any polyhedron the more faces the swatchesprovide, the closer the cup will approach the actual shape of thebreast.

Shown in FIG. 3 are four distinct and exemplary seams. A seam that joinsthe cradle to the cup is cup to cradle seam 32. This cup to cradle seam32 is significant because it often, in a conventional bra, makes up anunderwire casing. An underwire bra (also under wire bra, under-wire bra,or underwired bra) is a brassiere that utilizes a thin, semi-circularstrip of rigid material fitted inside the brassiere fabric. The wire maybe made of metal, plastic, or resin. It is sewn into the bra fabric andextends along the underside of each cup 14, extending from the centergore 22 to a spot on the cradle under the wearer's armpit. The wirehelps to lift, separate, shape, and support a woman's breasts. Theunderwire casing comprises a sturdy enclosure for the underwires andstabilizes the cup to cradle seam 32. Importantly, then, the placementof coils of wire, such as those that make up solenoids within the cup tocradle seam 32 is not unusual nor would the presence of those wiressignal that the wearer was undergoing any form of therapeutic treatment.

Each cup 14 is defined on its uppermost edge with a seam to finish thecup. That seam is referred to herein as the neckline seam 30. Just asare the seams discussed above and below, the neckline seam 30 can beconfigured to enclose wires of a solenoid to complete a leg of atriangular loop.

The placement of remaining seams as shown in FIG. 3 is merely one singleand exemplary configuration of the invention and others are certainlypossible and may be particularly advantageous for treatment of a tumorbased upon its location. From a fashion point of view, the more seamsthere are, the greater is the ability for the cup 14 to shape thebreasts. Seamed bras often fit better than their contour cupcounterparts and in the case of the instant invention, the more closelythe cup conforms with the breast, the better the opportunity to focuselectromagnetic fields upon tumors within the breast tissue. With aseamed bra, two or more pieces of fabric are selected to conform andaccent breast shape. Cosmetically, the seams also act to support thebreasts so the tissue can be lifted higher, shaped better and held in amore fixed relation to the seam-enclosed solenoids.

Fashion dictates that seaming across the cup can follow any of severalorientations; the three most common orientations found in conventionalbras are the diagonal seam, the horizontal seam and the vertical seam.In conventional fashion, all seams in a bra cup must cross the bustpoint 38, i.e. the fabric that immediately covers the nipple, or veryclose to it. By enclosing the solenoid in the seam, each solenoidextends from where the breast tissue contacts the chest wall to thenipple and this same orientation of seams, within a brassiere, allowsorientation of solenoids (contained within the seams of a bra) toexploit the principle of superposition thereby to focus fields at aspecific location within the volume of the breast as the localized pointfor therapeutic treatment.

A horizontal bra seam 36 will start and end at the cup to cradle seam 32extending over the bust point 38 generally within a plane parallel tothe horizon. Horizontal cups often incorporate the use of a split lowercup as shown in FIG. 3. Horizontal seams 36 are the seams of choice forstrapless bras or for cups that have a straight top edge—the horizontalseam 36 is then placed generally parallel to a top edge of each cup 14,and it creates a very balanced look to the cup 14. Cosmetically it isalso the best seaming choice for very large cups.

Another possible configuration not shown in FIG. 3 is that comprising adiagonal seam. Distinct from the horizontal seam 36, the diagonal seamhas its origination somewhere in the armhole curve of the cup 14,anywhere between a strap 16 attachment point and the cup to cradle seam32. Like a horizontal seam, the diagonal seam can be tilted higher orlower within its limited space, depending on the look or therapeuticcoverage that is desired. A high diagonal seam many feel is a moreflattering seamline for the wearer. It, too, can also be paired with asplit lower cup, although the split is often tilted more toward the sideseam, so as to form more of a “T” seam at the cross cup.

Still another possible configuration includes a vertical seamlinestarting anywhere along the top edge of the cup 14, between the strapattachment 16 point and the cup to cradle seam 32 in or near the gore22. A vertical seam starts anywhere along this edge.

As shown in FIG. 3, a vertical seam 34 transects the horizontal seam 36at the bust point 38 to define two seam segments: a medial horizontalseam 36 m and a distal horizontal seam 36 d. If one considers theencompassed breast as bounded by these three seam segments, the verticalseam 34, the medial horizontal seam 36 m and the distal horizontal seam36 d, the volume available for treatment would approximate a Reuleauxtetrahedron.

Referring to FIG. 4, then, the Reuleaux tetrahedron 14′ is a mapping ofthe right cup of the bra shown in FIG. 3 onto an idealized volume ofbreast tissue. Any Reuleaux tetrahedron is the intersection of fourcongruent spheres, each having radius s and centered at the vertices ofa regular tetrahedron with side length s. The sphere through each vertexpasses through the other three vertices, which also form vertices of theReuleaux tetrahedron. This and every Reuleaux tetrahedron 14′ has thesame face structure as a regular tetrahedron, but with curved faces:four vertices, and four curved faces, connected by six circular-arcedges. If the vertical seam 34 is mapped onto the Reuleaux tetrahedron14′ we will refer to the vertical seam as 34′, the medial horizontalseam 36 m is mapped as 36 m′, the distal horizontal seam 36 d is mappedas 36 d′ and the bust point 38 mapped as 38′. In a similar manner whenmapping the idealized breast onto the Reuleax tetrahedron 14′ one vertexcorresponds to the mapping of the bust point, and, thus, the nipple at38′. Consistent with the mapping of the right bra cup onto the Reuleauxtetrahedron 14′ and we see that the volume of the breast tissueavailable for treatment is approximated as:

${\frac{s^{3}}{12}\left( {{3\sqrt{2}} - {49\pi} + {162\; \tan^{- 1}\sqrt{2}}} \right)} \approx {0.422\; s^{3}}$

It is helpful when visualizing the placement of the solenoids todecompose the Reuleaux tetrahedron into four congruent pieces or hulls14 a-d, each being the convex hull of the centroid and one face (i.e.,each piece is the space between the center of mass of Reuleaux orspherical tetrahedron 14′ and a given face). The discrete volume of eachof the hulls 14 a-d is not significant as propagated magnetic fieldswill influence the whole of the right breast, but the separation intofour distinct but congruent hulls 14 a-d allows discussion of the edgesas distinct triangular solenoids and moves the reader into considerationof four distinct solenoids, each solenoid bordering a face, each facebeing defined by the seams of the cup.

Each of the four faces are a “Reuleaux spherical triangle,” a “circularspherical triangle” obtained by intersecting three circles having equalradius to that of the sphere. Each of circles goes through the centersof the other two. (A spherical triangle is a triangle on the spherewhose sides are arcs of great circles. Thus, a circular sphericaltriangle is what one gets when circular arcs replace the great circlesides.) In the instant invention, each face is bounded by a three seamswhich, together, approximate a Reuleaux spherical triangle and faces 14a-c correspond to panels of the right cup of the brassier. The fourthhull, 14 d is a mapping of the surface of the chest cavity where itcontacts the breast tissue.

FIG. 4 represents a mapping of the bra cup onto the Reuleaux tetrahedronand the further explosion of the Reuleaux tetrahedron into the fourhulls 14 a-d each having a face that is a Reuleaux spherical trianglebounded by the mapping of seams onto the hulls 14 a-d. Each seam can beexploited to discretely house a series of coils for generation of amagnetic field at the site of target tissue.

Considering, then, each of the hulls 14 a-d shown in FIG. 4 in order:

-   -   Hull 14 a is bounded by the mapping of the distal horizontal        seam 36 d′, the mapping of the medial horizontal seam 36 m′ and        the mapping of neckline seam 30′. The bust point is mapped to        one vertex 38′. The Releaux spherical triangle that is the face        of hull 14 a would be referred to as an upper cup panel in the        parlance of bra manufacture;    -   Hull 14 b is bounded by the mapping of the distal horizontal        seam 36 d′, the mapping of a segment (extending from cradle 20        at the distal horizontal seam 36 d to the vertical seam 34) of        the cup to cradle seam 32 a′ and the mapping of vertical seam        34′. Again, the bust point is mapped to one vertex 38′. The        Releaux spherical triangle that is the face of hull 14 b would        be referred to as a cradle side cup split panel in the parlance        of bra manufacture;    -   Hull 14 c is bounded by the mapping of the medial horizontal        seam 36 m′, the mapping of a segment (extending from gore 22 at        the medial horizontal seam 36 m to the vertical seam 34) of the        cup to cradle seam 32 b′, and the mapping of vertical seam 34′.        This third hull 14 c is the last to share the bust point, which        is mapped to one vertex 38′. The Releaux spherical triangle that        is the face of hull 14 c would be referred to as a gore side cup        split panel in the parlance of bra manufacture;    -   Hull 14 d is bounded by the mapping of the neckline seam 30′,        the mapping of the distal horizontal seam 36 d′, the mapping of        the segment (extending from cradle 20 at the distal horizontal        seam 36 d to the vertical seam 34) of the cup to cradle seam 32        a′, and the mapping of the segment (extending from gore 22 at        the medial horizontal seam 36 m to the vertical seam 34) of the        cup to cradle seam 32 b′. The Releaux spherical triangle is not        a part of the bra as its boundaries define the rim of the right        cup 14 and admit the breast to enclose its volume. There is no        corresponding panel of the brassiere.

In use, then, the cup for the breast containing the tumor would receive,in this exemplary embodiment, four distinct low frequency signals; eachsignal independently energizing the solenoid coils in each of the panelsdefined by the seams. The independent signals allow the focusedapplication of magnetic and electric field in an closely circumscribedvolume that contains the tumor. So, for example the six seams the distalhorizontal seam 36 d, the medial horizontal seam 36 m, the neckline seam30; the cup to cradle seam 32 a, the cup to cradle seam 32 b, and thevertical seam 34 define the boundaries of the three panels and theopening to the brassiere. The vertical seam 34 joining the distalhorizontal seam 36 d and the medial horizontal seam 36 m at the bustpoint 38. Each permutation of the seams defines one region of thebrassiere 10, each region being bounded by a distinct solenoid suchthat, as demonstrated in FIG. 4, four distinct solenoids bound fourdistinct hulls, three of which are represented by distinct panels in thebrassiere (the fourth region is bounded by the cup to cradle seam 32 andthe neckline seam 30 but is really behind this projection of the rightbrassiere cup 14 and not shown herein).

By selectively energizing each solenoid, i.e. 1 (the upper cup), 2 (thedistal split cup), 3 (the medial split cup), and 4 (the opening), acontrol unit can generate each an electric and a magnetic field withinthe volume of the breast. Advantageously, because the Nativis work isbased upon application of specific, low energy, non-invasive,non-thermal and non-ionizing oscillating electromagnetic signals, thesefour solenoids can reconstruct, as the sum of their individual fields,signals to inhibit in vitro tumor cell proliferation. Thesereconstructed signals ought to be able to produce a more localizedanti-mitotic effect than the single solenoid Nativis relies upon todate. Methods: Conventionally, the Nativis Voyager™ relies uponpropagation of a single RFE signal applied using a rectangular 40 mGcoil. One can readily surmise that within a system based upon generatinga localized field signal like that of the Nativis Voyager™ RFE Systemonly to do so at the precise site of the tumor rather than on thatsurface of the breast closest to the tumor, tumor growth would besimilarly interrupted. Because the fields would reach their maximumstrength only at the tumor site, side effects would be minimized.Because the magnetic field of the summation of the contributions fromeach of the coils, the noncancerous tissue would be minimally affected.In short, the instant invention will be maximally effective inadministering focused fields because of the distinct orientations ofmultiple solenoids.

While the preferred embodiment of the invention has been illustrated anddescribed, as noted above, many changes can be made without departingfrom the spirit and scope of the invention. Accordingly, the scope ofthe invention is not limited by the disclosure of the preferredembodiment. Instead, the invention should be determined entirely byreference to the claims that follow.

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:
 1. A brassiere toadminister electromagnetic therapy to treat a cancerous tumor within abreast, the brassiere comprising: at least one cup, the cup comprisingat least: a first magnetic coil to receive a first time-domain signalconsisting of a first series of summed sinusoidal waves from a firstpower supply, the first series of summed sinusoidal waves beingrepresentable as a first set of coefficients in a first Fourier series;and a second magnetic coil to receive a second time-domain signalconsisting of a second series of summed sinusoidal waves from a firstpower supply, the second series of summed sinusoidal waves beingrepresentable as a second set of coefficients in a second Fourierseries, wherein the first magnetic coil and the second magnetic coil areoriented relative to each other so as to be nonparallel, the first setof coefficients in the first Fourier series and the second set ofcoefficients in second Fourier series being selected such that aresultant first combined electrical field formed by superposition formsa local maximum at the cancerous tumor.
 2. The brassiere of claim 1,further comprising: a third magnetic coil to receive a third time-domainsignal consisting of a third series of summed sinusoidal waves from athird power supply, the third series of summed sinusoidal waves beingrepresentable as a third set of coefficients in a third Fourier series,wherein the first magnetic coil, the second magnetic coil, and the thirdmagnetic coil are oriented relative to each other such that each pair ofmagnetic coils is nonparallel one to the other, the first set ofcoefficients in the first Fourier series, the second set of coefficientsin second Fourier series, and the third set of coefficients in the thirdFourier series being selected such that a resultant second combinedelectrical field formed by superposition forms a local maximum at thecancerous tumor.
 3. The brassiere of claim 2, further comprising: afourth magnetic coil to receive a fourth time-domain signal consistingof a fourth series of summed sinusoidal waves from a fourth powersupply, the fourth series of summed sinusoidal waves being representableas a fourth set of coefficients in a fourth Fourier series, wherein thefirst magnetic coil, the second magnetic coil, the third magnetic coil,and the fourth magnetic coil are oriented relative to each other suchthat each pair of magnetic coils is nonparallel one to the other, thefirst set of coefficients in the first Fourier series, the second set ofcoefficients in the second Fourier series, the third set of coefficientsin the third Fourier series, and the fourth set of coefficients in thefourth Fourier series being selected such that a resultant thirdcombined electrical field formed by superposition forms a local maximumat the cancerous tumor.
 4. The brassiere of claim 3, wherein each of thefirst, second, third and fourth magnetic coils are positioned within thebrassiere to approximate edges of four respective hulls that togetherapproximate a Reuleaux tetrahedron.
 5. The brassier of claim 1, whereinthe brassiere cup further comprises a plurality of seams, the seamsenclosing the magnetic coils.
 6. A method to administer electromagnetictherapy to treat a cancerous tumor within a breast, the methodcomprising: providing a brassiere having at least one cup comprising atleast a first magnetic coil and a second magnetic coil; providing to thefirst magnetic coil a first time-domain signal consisting of a firstseries of summed sinusoidal waves from a first power supply, the firstseries of summed sinusoidal waves being representable as a first set ofcoefficients in a first Fourier series; and providing to the secondmagnetic coil a second time-domain signal consisting of a second seriesof summed sinusoidal waves from a first power supply, the second seriesof summed sinusoidal waves being representable as a second set ofcoefficients in a second Fourier series, wherein the first magnetic coiland the second magnetic coil are oriented relative to each other so asto be nonparallel, the first set of coefficients in the first Fourierseries and the second set of coefficients in second Fourier series beingselected such that a resultant first combined electrical field formed bysuperposition forms a local maximum at the cancerous tumor.
 7. Themethod of claim 6, further comprising: energizing a third magnetic coilthe brassiere comprises with a third time-domain signal consisting of athird series of summed sinusoidal waves from a first power supply, thethird series of summed sinusoidal waves being representable as a thirdset of coefficients in a third Fourier series, wherein the firstmagnetic coil, the second magnetic coil, and the third magnetic coil areoriented relative to each other such that each pair of magnetic coils isnonparallel one to the other, the first set of coefficients in the firstFourier series, the second set of coefficients in second Fourier series,and the third set of coefficients in the third Fourier series beingselected such that a resultant second combined electrical field formedby superposition forms a local maximum at the cancerous tumor.
 8. Themethod of claim 7, further comprising: energizing a fourth magnetic coilthe brassier comprises with a fourth time-domain signal consisting of afourth series of summed sinusoidal waves from a first power supply, thefourth series of summed sinusoidal waves being representable as a fourthset of coefficients in a fourth Fourier series, wherein the firstmagnetic coil, the second magnetic coil, the third magnetic coil, andthe fourth magnetic coil are oriented relative to each other such thateach pair of magnetic coils is nonparallel one to the other, the firstset of coefficients in the first Fourier series, the second set ofcoefficients in the second Fourier series, the third set of coefficientsin the third Fourier series, and the fourth set of coefficients in thefourth Fourier series being selected such that a resultant thirdcombined electrical field formed by superposition forms a local maximumat the cancerous tumor.
 9. The method of claim 8, wherein the each ofthe first, second, third and fourth magnetic coils are positioned withinthe brassiere to approximate edges of four respective hulls thattogether approximate a Reuleaux tetrahedron.
 10. The brassier of claim6, wherein the brassiere cup further comprises a plurality of seams, theseams enclosing the magnetic coils.
 11. A brassiere assembly toadminister electromagnetic therapy to treat a cancerous tumor within abreast, the brassiere assembly comprising: a brassiere having at leastone therapeutic cup, the therapeutic cup including a plurality ofsolenoid coils, the coils in nonparallel alignment, each to the others;and a signal generator for independently energizing each of theplurality of solenoid coils.
 12. The brassiere assembly of claim 11wherein the signal generator comprises: a Fourier summing engine togenerate summed signals by summing of sinusoids based upon Fouriercoefficients provided to the summing engine.
 13. The brassiere assemblyof claim 12 wherein each of the plurality of solenoid coils receives adistinct signal based upon a distinct series of Fourier coefficientsprovided to the Fourier summing engine.
 14. The brassiere assembly ofclaim 13 wherein each of the distinct series of Fourier coefficients areselected to generate a designated field at a tumor site within a volumeof breast tissue the therapeutic cup encloses, summed from the influenceof the plurality of solenoid coils based upon the superpositionprinciple.
 15. The brassiere assembly of claim 14 wherein the designatedfield is selected to mimic electromagnetic fields associated withtherapeutic dosage of cancerous tissue with a selected anti-cancer drug.